Abbott announced it has received approval from the US Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The new Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer’s approved NSCLC therapy, Xalkori (crizotinib), an oral first-in-class ALK inhibitor.

The Vysis ALK FISH test uses Abbott’s fluorescence in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome.

The diagnostic test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy.

"The Abbott-Pfizer collaboration marks a breakthrough in the advancement of personalized medicine – and companion diagnostics specifically – that will help a subset of lung-cancer patients get treatment tailored to their unique genetic profile," said Stafford O’Kelly, head of Abbott’s molecular diagnostics business.

The simultaneous FDA approvals are expected to change clinical practice for the diagnosis and treatment of patients with NSCLC. The Abbott ALK test has been designed to identify those patients – about 3 to 5 per cent of NSCLC patients – who would be candidates for the new drug.

"The FDA’s priority and expedited review process of the drug and combination diagnostic test have been impressive," O’Kelly said. "We expect that many patients newly diagnosed with NSCLC will want to ask their doctors about the potential benefits of this new genetic test."

Lung malignancies are the leading cause of cancer deaths worldwide, with more than 1.6 million new cases diagnosed each year. About 85 per cent of lung cancer patients have the non-small-cell type and are usually diagnosed with advanced disease having a very low survival rate.

FISH (fluorescence in-situ hybridization) technology has a variety of uses.

It can identify whether too many, or too few, copies of a particular gene are present in the body’s cells or whether certain genes have rearrangements that play an active role in disease progression. Since the technology works especially well for identifying genetic markers in solid tumours, cancer diagnostics are one of the fastest growing applications.

Similar to the Abbott ALK test’s ability to identify patients for Xalkori therapy, Abbott's PathVysion test, the first FDA approved FISH-based companion diagnostic, detects amplification of the HER-2 gene and acts as an aid in identifying patients for Herceptin (trastuzumab) therapy for breast cancer. The Abbott UroVysion test also utilizes FISH technology to quantitatively assess chromosomal changes in the cell’s nucleus, which may aid in the diagnosis as well as in the surveillance and monitoring of bladder cancer.

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential for earlier detection or diagnosis, can influence the selection of appropriate therapies, and may improve monitoring of disease progression.


Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.